Clinical center of Montenegro

ENVIRONMENTAL MANAGEMENT PLAN (EMP) FOR

THE HERIC PROJECT

“HLA typing and HLA laboratory in Montenegro” (HLA - MNE)

-Draft-

Project Leader: prof. dr Marina Ratković

______

In Podgorica, June2017

Contents

1.INTRODUCTION

1.1. Project description

2.ACTIVITIES IN HLA-MNE PROJECT BY WORK PACKAGES (WP-s) AND THEIR POSIBLE NEGATIVE IMPACTS ON THE ENVIRONMENT

3.DESCRIPTION OF ACTIVITIES WITH POSSIBLE AND WITH IDENTIFIED ENVIRONMENTAL IMPACT

3.1 Renovation of the laboratory

3.2 Laboratory works

4.LEGAL FRAMEWORK

5.PROPOSED PREVENTION A NDMITIGATION MEASURES

5.1. Measures for minor civil works on renovation of the laboratory

5.2. Measures during regular works of laboratory

5.3. Capacity building for HLA laboratory

ENVIRONMENTAL MANAGEMENT PLAN

Annex 1 Check list and EMP for minor civil works

Annex 2 Report on public consultation

1.INTRODUCTION

The Ministry of Science announced the Second Call for Research and Development Project Grants (CRDS) on May 20th 2014 and it was opened until September 19th2014. After a two-stage of the external evaluation, the project of Clinical Center of Montenegro“HLA typing and HLA laboratory in Montenegro”(HLA - MNE), coordinated byprof. dr Marina Ratkovićis ranked as the highly recommended that will be funded over the next two years.

The project activities fall into screening category II (B) according to the World Bank rules and require development of the Environmental Management Plan (EMP).

1.1. Project description

CONSORTIUM

Thisproposalencompasses:

  • Clinical Center of Montenegro(KCCG), RSRI[1]
  • School of Medicine-University of Montenegro (MedF), RSRI
  • Clinical Center of Zagreb (KC Zagreb),ISRI[2]
  • R.O.S.E.GenTec Ltd. (ROSE),IL[3]

Intotal3scientificorhigheducationinstitutionsandonebusinesspartners are involved in HLA-MNE project.

SUMMARY (BACKGROUND OF THE PROJECT)

The project would have as a goal the establishment of resources and capacity in the health system of Montenegro for performing HLA typing and other immunological tests required for transplantation program in general and for HLA typing in general population.Introduction of HLA laboratory would have the importance for population HLA typing, diagnosis of other diseases, not only for the preparation and selection of patients for transplantation. Endemic diseases that occur in Montenegro could be traced and monitored in this way.It was planned that the project would take two years. It started in September 2015 to be finalized by September of 2017, but it should be extended for a year.In general, the project would include theadaptation of existing space of the laboratory for immunological research and purchase of the equipment and materials for laboratories performing HLA typing and its application, training and education of the staff and HLA typing for patients.

LOCATION OF THE PROJECT ACTIVITIES IN MONTENEGRO

All projectactivitieswillbedoneat the Clinical Center of Montenegroin Podgorica.

2.ACTIVITIES IN HLA-MNE PROJECT BY WORK PACKAGES (WP-s) AND THEIR POSIBLE NEGATIVE IMPACTS ON THE ENVIRONMENT

ActivitiesinHLA-MNEprojectbyWP-s/
Institutionsfor implementation / Possible impact
During project
implementation / Beyond project implementation
WP1. Purchase of HLA equipment/
KCCG, MedF, KC Zagreb
1.1. / Finalization of specification of equipment / NO / NO
1.2. / Choosing of the supplier / NO
ory / No
1.3. / Delivery of the equipment / NO / NO
1.4. / Public advertisement for admission molecular biologist and two lab technicians for the project / NO / NO
1.5. / Selection of candidates
uns / NO / NO
1.6. / Delivery of the equipment / NO
*
( / NO
WP 2. Installation and bringing to use of the equipment/
KCCG, MedF,
KC Zagreb
2.1. / Adaptation of existing space of the Laboratory for immunological research / YES (minor civil works) / NO
2.2. / Installation of new equipment / NO / NO
WP 3. Education of medical staff/
KC Zagreb, KCCG, ROSE
3.1. / Organisation of trainings in Clinical Hospital Center Zagreb – for physicians / NO / NO
3.2. / Organisation of trainings in Clinical Hospital Centre Zagreb – for medical laboratory technicians
- Identification of potentials for agro-tourism product/experience development and diversification / NO / NO
3.3. / Ad hoc trainings on-the-spot in Podgorica / No / NO
3.4. / Production of a standard Code of practice for HLA typing in HLA laboratory in MNE / NO / NO
WP 4. HLA typing for patients)/
KCCG, MedF,KC Zagreb, ROSE
4.1. / Selection of patients for living related kidney transplantation and for cadaveric transplantation - / YES (Laboratory safety) / YES (Laboratory safety)
4.2. / HLA typisation and other immunological research in preparation for kidney transplantation / YES (Laboratory safety) / YES (Laboratory safety)
4.3. / Immunological research in transplanted patients which is necessary for diagnosis / YES (Laboratory safety) / YES (Laboratory safety)
4.4. / Immunological research in special groups of patients (rheumatology, hematology and genetic diseases) / YES (Laboratory safety / YES (Laboratory safety
4.5. / Testing and wide use of new technologies for the genetic corpus of Mediterranean – Balkan type of patients / YES (Laboratory safety / YES (Laboratory safety
4.6. / Development of treatment protocols for specific groups of patients / NO / NO
WP 5. Management/
KCCG, KC Zagreb, ROSE
5.1. / Strategic Advisory management / NO / NO
5.2. / Scientific supervision / NO / NO
5.3. / Operational human resources and financial management / NO / NO
WP6. Dissemination/
KCCG, ROSE
6.1. / Preparation of the visual identity of the project and all the printed materials (subcontracting) / NO / NO
6.2. / Preparation of the media communications plan / NO / NO
6.3. / Development of the web-page of the project (subcontracting) / NO / NO
6.4. / Preparation of regular press-releases / NO / NO
6.5. / TV and radio shows visits of the key personnel of project / NO / NO

3.DESCRIPTION OF ACTIVITIES WITH POSSIBLE AND WITH IDENTIFIED ENVIRONMENTAL IMPACT

Activities with possible and with identified environmental impact from WP2 and WP4 will be implemented in the new-established HLA-laboratory in Clinical centre in Podgorica.

3.1 Renovation of the laboratory

WP.2.1- Adaptation of existing space of the Laboratory for immunological research; Here the key environmental safeguard issues are primarily related to civil works on renovation of the laboratory.

The premises for new laboratory is placed on the first floor of Clinical centre (Department for blood transfusion in previous period). The surface of the space is 135.85 m². Water supply and sewage system have been already installed, also ventilation and electricity; New equipment and connection will be adjusted following of the current installation. The heating system is in function, so there is need for changing of this installation. Air-conditioning is planned by using of multi- split system, also adequate ventilation of the rooms will be ensured. Interior works are planned only (plastering, tilling works, painting works etc).

3.2 Laboratory works

WP 4.1, 4.2., 4.3., 4.4 and 4.5 –immunological research in HLA laboratory; these are the activities related to regular works of the laboratory after renovation and equipping. Herethekeyenvironmentalsafeguardissuesareprimarilyrelatedto laboratorysafetyanddisposalofwaste.

The following material will be used during laboratory investigation:

  • Blood samples (serum, blood with heparin, EDTA Blood)
  • Tissue samples (lymph node, clips of the spleen)

The following laboratory procedures will be performed:

  • Isolation of lymphocytes by density gradient centrifugation
  • Test of microlymphocytotoxicity in micro titer Terasakiplate, including reading of the results by using of light microscope
  • Isolation of DNA
  • Amplification of DNA by using of PCR in the apparatusfor amplification (thermocycler)
  • Electrophoresis of amplified DNA fragments and reading of the results on UV table
  • Luminextestings - PCR-SSO typing of antibodies and tests for determining of antibodies

The following chemicals and tests will be used: Lymphoprep, Hanks medium, serum AB, distilled water, physiological saline, trypan blue, rabbit complement, paraffin oil, ethanol, SDS, Proteinase K, buffers for isolation of DNA, PCR buffer, a buffer for electrophoresis, agarose, migration length marker, gel- red, serological tests for HLA typing, serological tests for the determination of antibodies HLA.

The list of laboratory equipment for HLA typization:

  • High speed centrifuge
  • Centrifuge
  • Medical Laboratory freezer
  • Medical laboratory refrigerator
  • Automatic pipette, variable volume
  • Automatic DNA isolation system
  • PCR workstation
  • Horizontal electrophoresis
  • Thermalcycler
  • Device for anti-HLA antibodies detection Luminex
  • Fluorescent microscope
  • Microscope adjusted for cross match
  • Thermoshaker
  • Vorthex mixer
  • Camera with UV transilluminator
  • Kits for PCR and post PCR
  • Genetic analyzer sequenator with software

The standard working conditions are envisaged for the laboratory in terms of lighting , noise and space (there are no special requirements); air conditioning required in areas with apparatus (Luminex, PCR) and refrigerators. The devices should be connected on security socket (in case of a power failure, they immediately will be transferred to the generator).

Infectious waste will be generated from blood samples and everything that comes in contact with them. Radioactive and carcinogenic waste will not be generated. In addition, chemical waste and sharps will be also generated during laboratory works.

These activities do belong to the activities for which full Environmental Impact Assessment (EIA) is not required, in accordance with Law on EIA.

4.LEGAL FRAMEWORK

Theproposal ofthe HLA in MNEproject ismadefollowing thelawsofMontenegro, rulesofthe World Bank and international guidelines. Montenegro, as a candidate for the Member State has imperativetoharmonizeregulationsinthedomainofpublichealthandenvironment protectionwith EUlegislative.Inthatsensethreeimportantdraftsofenvironmental relatedlawswereadopted, in accordance with EU directives:

Law on EnvironmentalProtection

Law on Environmental Impact Assessment and

Lawon IntegratedPreventionandPollution Control.

Other applicable Montenegrin regulations:

LawonWasteManagement

LawonChemicals

Law on Water

Law on Health Care

Law on Medical Means

Law on Taking and Transplantation of Human Organs for Medical Treatment Purposes

Law on Taking and Transplantation of Human Tissues and Cells for Medical Treatment Purposes.

Taking into account that the Project activities could induce the impacts that can be readily identified and standard preventative and/or remedial measures can be prescribed without a full EIA as per the Law on Environmental Impact Assessment, the Project corresponds to World Bank Category B and requires development of EMP.InternationalBestPracticeinSafetyofResearchLaboratories is also applicable for the project activities.

5.PROPOSED PREVENTIONA NDMITIGATION MEASURES

Thereisa needformitigationmeasuresforthefollowing activities:

WP.2.1-Adaptation of existing space of the Laboratory for immunological research; Here the key environmental safeguard issues are primarily related to civil works on renovation of the laboratory.

WP 4.1., 4.2., 4.3., 4.4 and 4.5 - related to immunological research in HLA laboratory. Herethekeyenvironmentalsafeguardissuesareprimarilyrelatedto laboratorysafetyanddisposalofwaste.

5.1. Measures for minor civil works on renovation of the laboratory

The premises for new laboratory is placed on the first floor of Clinical centre (Department for blood transfusion in previous period). The surface of the space is 135.85 m². Interior works are planned only (plastering, tilling works, painting works etc). Check list with the EMP for minor civil works have been prepared to be implemented during renovation works (Annex 1). This document should be a part of tender documentation for contracting of the civil works.

5.2. Measures during regular works of laboratory

For all activities in WP4 listed above, prevention and mitigation measures are needed. Allplanedactionsineliminating environmentalimpactwill beonlinewiththelegalframeworkandInternationalBestPracticeinSafetyofResearchLaboratories.

Chemicals and laboratory safety

In the HLA laboratory usualbestpracticeinsafetyoflaboratorieswillbeused:

Minimization of materials acquisitionofhazardous.

For chemical substances, Material Safety Data Sheets – MSDSs are available to all laboratory staff thatis trained to handle them.

Chemicals and tests are duly marked, stored in proper places with restricted access, available to the laboratory staff only, not on bench tops or lab hoods and not exposed heat or direct sunlight.

In laboratory storage refrigerators will be in use for storing chemicals and tests for which it is necessary.

Laboratory will have fire protection system.

Laboratory personal will use appropriate personal protection materials/means to minimize exposure.

The special care will be used when using sharps.

In laboratorywill be established good housekeeping with decontamination of work surfaces.

In laboratoryis forbidden eating, smoking, handle contact lenses, apply cosmetics, or take medicine.

Access to the laboratory is granted to the authorised persons only.

Expired chemicals, tests and other chemical waste are stored and kept before final disposal by licensed waste manager.

Medical waste will be sorted in a special way, to be collected before final disposal by licensed company.

Each device is marked with an inventory number and accompanied by registration sheet which specifies all the characteristics (date of procurement, servicing, position in laboratory etc.).

Additional measures thatwillbeintroducedintotheworkingpracticesin HLA laboratory:

Onthelaboratoryappropriatewarningsignsandlistoftelephonenumbersto callincaseofaccident willbeplaced.

System for registration, reporting and treatment of injuries of staff members will be established.

Guide for safe storage, handling and disposal of waste will be prepared.

Waste management

There is the system for collecting, segregation, treatment and final disposal of different types of waste that had been established in Clinical center of Montenegro earlier, in which new HLA laboratory will be included. Waste management plan developed by Clinical center(and approved by Environmental Protection Agency in December 2015) provides among other information about types of all generated waste and rules for management with each type of waste (collecting and segregation, storage, transport and final disposal). All waste produced in HLA lab will be treated on a proper way as it has already introduced in other laboratories of Clinical center.

The following types of hazardous waste should be generated during regular work of HLA laboratory: medical waste (infectious waste and sharps)as well as chemical waste. In addition different types of non-hazardous waste such as municipal waste will be generatedto be disposed in municipal containers.

Medical and chemical waste

Medical waste such as infectious waste and all sharps that will be generated from blood samples and everything that comes in contact with them will be stored separately in special containers properly marked. Medical waste already segregated and marked is transported from the laboratories and other points to the Center for treatment of medical waste established by authorized company, which is located near the Clinical center. All the time, waste transportation and final disposal in the Center for treatment of medical waste is followed with proper evidence/documentation.

Chemical waste (expired chemicals and tests, packages of chemicals and tests etc) will be stored separately in special properly marked containers. This type of waste will be collected by authorized waste manager (the system has already been established for the Clinical center as a whole).

5.3. Capacity building for HLA laboratory

Guide for safe storage, handling and disposal of waste will be prepared. Laboratory should provide additional training in the fields of laboratory safety and waste management for all the laboratory staff members. Partner institution Clinical Center of Zagreb will transfer its knowledge to the Montenegrin partners about laboratory safety within WP3-Education of medical staff since they have extensive experience in that field.

ENVIRONMENTAL MANAGEMENT PLAN

A)MITIGATIONPLAN

Phase or WP / Issue / Mitigating measure / Cost / Responsibility / Supervision(to be filled in during supervision)
WP4 / Risk of contamination and health risks from
human blood and tissue sampling and testing / -The sampling and testing will be done by professional medical staff in accordance with applicable medical procedures
-Sharps will be collected in puncture-proof containers and fitted with covers, and marked
-Personal protection materials and equipment will be used
-All other safety measures will be used (decontamination of work surfaces, prohibition measures, using of sharps with special care)
- Setting appropriate warning signs and list of telephone numbers to call in case of accident in laboratories / No / HLA laboratory
WP4 / Risk of contamination and health risk from improperly managed of chemicals, tests and handling with different types of waste / -Chemicals and tests are stored in proper places with restricted access
-Labeling inventory will be properly done
-Storage refrigerators are in use for storing biochemical and tests
-Fire protection system is in function
-Handling of waste will include separate collection and storage of laboratory waste / No / HLA laboratory
WP4 / Risk of non-adequate handling with laboratory goods and chemicals which could endanger stuff health, also as environment / Training of the HLA laboratory staff on the laboratory safety and the waste management / No
Within Project budget / HLA laboratory supported by Clinical center Zagreb
WP2 / Risk of the pollution during renovation of the laboratory / Elaborated in a separate document -Checklist with the EMP for minor civil works, Appendix 1 / No, within the budget for civil works / Contractor

B)MONITORING PLAN

WP / What parameteristo bemonitored? / Whereisthe parameterto be monitored? / Howistheparametertobemonitored/typeof monitoring equipment? / Whenistheparametertobe monitored-frequencyofmeasurementor continuous? / MonitoringCost -Whatisthecostof equipmentor contractorcharges toperform monitoring? / Responsibility
WP4 / Management withthe laboratory waste
materials / HLA lab / Internal inspections will be undertaken, control of waste flow followed with appropriate documentation / twiceperyear / No / Clinical center of Montenegro
WP4 / TrainingoftheHLA labstaff relatedtothe lab safety and hazardouswaste management / HLA lab / Report on training / Once a year / No / Clinical center of Montenegro supported by Clinical center Zagreb
WP4 / Guide for safe storage, handling and disposal of waste will be prepared / HLA lab / Guide will be exposed in the labs and available to all users / Three months after establishing of the laboratory / No / Clinical center of Montenegro

Annex 1

Checklist and EMP for Minor Civil Works on renovation of a part of the first floor within the

main building of Clinical center in Podgorica-HLA laboratory

PART 1: INSTITUTIONAL & ADMINISTRATIVE
Country / Montenegro
Project title / “HLA typing and HLA laboratory in Montenegro” (HLA in MNE)
Scope of project and activity / Government of Montenegro has implemented the project Higher Education and Research for Innovation and Competitiveness - HERIC, which is financed from the loan of the World Bank. Within the component 3.2. (CRDS grants),Ministry of Science granted the project “HLA typing and HLA laboratory in Montenegro” (HLA in MNE) of the Clinical center of Montenegro. One of the planned activities is renovation of a part of the first floor within the main building of the Clinical center where the HLA laboratory will be established.
It is planned the renovation and adapting to the purpose of the space of 135.85 m2. The access to the premises is possible over the stairs with a separate entrance, and through the corridor with administrative facilities. In the previous period, the space served for the Department of Blood Transfusion, however, that this department is now obtained new premises, this space is left unused. The premises for HLA lab is envisaged here, which would include:
-rooms for the equipment
-office for computer processing
-cold chambers +4 and +8°C
- checking room
- kitchenette
-sanitary facilities
During the work on renovation, the interior built walls are retained where possible, while new wallsare planned as prefabricated walls of modern lightweight materials.The interior of the walls predicted, depending on the purpose of premises, processing with dispersive paint and ceramic tiles.Final processing includes vinyl floor , with a combination of ceramic tiles in the toilets. The external look of the building is retained, but is not intended the replacement of facade joinery, because the plan is that it will be changedwithin the other project.
Water supply and sewage system have been already installed, also ventilation and electricity; New equipment and connection will be adjusted following of the current installation. The heating system is in function, so there is need for changing of this installation. Air-conditioning is planned by using of multi- split system, also adequate ventilation of the rooms will be ensured.
Institutional arrangements
(Name and contacts) / WB
(Project Team Leader)
Roberta Malee Bassett
/ Project Management
Director of the HERIC Project: DarkoPetrušić
Manager of the Project:
SasaIvanovic
Environment Consultant:
Ilinka Beatović Nikić
/ Local Counterpart and/or Recipient
Clinical center of Montenegro
Director: ZoricaKovacevic
Leader of the project HLA in MNE:
Dr Marina Ratkovic

Implementation arrangements
(Name and contacts) / Safeguard Supervision
WB safeguard expert:
Nikola Ille

Environmental Consultant:
Ilinka BeatovićNikić
/ Local Counterpart Supervision
Will be contracted. / Local Inspectorate Supervision
Environment inspectorate
Construction inspectorate
Communal police
Labour inspectorate / Contractor
Will be contracted.
SITE DESCRIPTION
Name of site / Clinical center of Montenegro, Podgorica
Describe site location / Clinical center of Montenegro is situated in the urban zone of Podgorica, on the address Ljubljanska street. / Attachment 1: Site Map [ ]Y [x] N
Who owns the land? / Clinical center of Montenegro
Geographic description / Podgorica
LEGISLATION
Identify national & local legislation & permits that apply to project activity / The following regulation related to spatial planning and building of the structures is applicable :
Law on Spatial Planning and Construction (OG of Montenegro No 51/08, 40/10, 34/11, 47/11, 35/13, 39/13 and 33/14).
Rulebook on the design and the content of technical documentation (OG of Republic of Montenegro No 22/02 and 23/14).
Environmental regulation that are applicable on planned activities are:
The Law on Environment (OG of Mne No 52/16)
The Law on Waste Management (OG of Mne No 64/11, 39/16)
The Law on Protection from Noice in the Environment (OG of Mne No 28/11, 01/14)
The Law on Air Protection (OG of Mne No 25/10,40/11, 43/15)
Considering that it is a project of renovation, the project does not require a building permit, but the works should be reported to the competent authority.
PUBLIC CONSULTATION
Identify when /where the public consultation process took place
INSTITUTIONAL CAPACITY BUILDING
Will there be any capacity building? / [ x] N or [ ]Y if Yes, Attachment 2 includes the capacity building program

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